Treatment of Chemotherapy-induced Nausea and Vomiting - Full Text View

Sponsor:	Uppsala University Hospital
Information provided by:	Uppsala University Hospital
ClinicalTrials.gov Identifier:	NCT01101529

Purpose

Delayed nausea is a common problem after high dose chemotherapy for bone marrow transplantation. This study wants to compare standard prophylactic anti-emetic therapy with the same treatment plus the drug aprepitant (Emend). The hypothesis is that addition of Emend will reduce nausea and vomiting.

Condition	Intervention	Phase
Nausea Vomiting	Drug: Aprepitant (Emend) Drug: Placebo	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Randomized Controlled Study to Compare (EMEND®)to Standard Treatment as Prevention for Delayed Chemotherapy-induced Nausea and Vomiting (CINV) After Myeloablative Therapy for Patients Undergoing Autologous Stem Cell Transplantation.

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Aprepitant

U.S. FDA Resources

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:

Vomiting and nausea [ Time Frame: 7 days ] [ Designated as safety issue: No ]
The proportion of patients with a complete response (no vomiting and/or only mild nausea and no use of rescue therapy) a/ during chemotherapy and b/ in the delayed phase (up to 7 days after end of chemotherapy).

Secondary Outcome Measures:

Safety and tolerability of the aprepitant regimen for CINV [ Time Frame: 3 weeks ] [ Designated as safety issue: Yes ]
Possible side effects will be recorded, and all AE:s reported during 3 weeks after the chemotherapy.

Estimated Enrollment:	90
Study Start Date:	May 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Standard antiemetic therapy plus placebo Standard anti-emetic prophylaxis consisting of 1/dexamethasone 6 mg daily during the chemotherapy days and 2/tropisetron (Navoban)5 mg daily during chemotherapy and 2 days after	Drug: Placebo Placebo will be administered instead of Emend Other Name: Placebo
Experimental: aprepitant (Emend) Aprepitant given orally 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after as an addition to standard antiemetic therapy as in the placebo arm.	Drug: Aprepitant (Emend) Aprepitant will be added to the standard anti-emetic therapy. Emend is given orally, 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after Other Name: Emend

Detailed Description:

A single centre randomized placebo-controlled phase II-study with a random assignment to experimental (EXP) or control (CTR) group. All patients with lymphoproliferative diseases ≥18 years of age, scheduled for myeloablative therapy before autologous stem cell transplantation at the Akademiska University Hospital in Uppsala, Sweden, will be included consecutively during one and a half year. A total of 90 patients (45 per treatment arm) will be accrued for this study. They will be invited by mail to participate in the study a couple of weeks before hospital entry. A random assignment to EXP or CTR will be performed by research nurses not participating in any other way in the study. Patients will be stratified for diagnosis which also means myeloablative therapy (lymphoma (BEAC) or myeloma (high-dose melphalan)), and the groups are expected to be similar in size. One box for each diagnosis (lymphoma and myeloma) will contain equal numbers of randomisation cards for the experimental and control groups, randomly mixed within each box. Cards will be picked consecutively by a research nurse not otherwise involved in the study. The EXP group will receive aprepitant (EMEND®) in combination with standard anti-emetic treatment and the CTR group will receive standard anti-emetic treatment. All treatment will be given in the hospital.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥18 years
Able to communicate in Swedish
Diagnosis of lymphoproliferative disease
Scheduled for myeloablative therapy and autologous stem cell transplantation
Written informed consent
Able to swallow oral medications

Exclusion Criteria:

Nausea at baseline (immediately before start of chemotherapy)
Gastrointestinal obstruction or active peptic ulcer
Current illness requiring chronic systemic steroids or requirement for chronic use of antiemetic agent(s)
Hypersensitivity to any component of the study regimen
Pregnancy or nursing
Unrelenting hiccups
Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
Psychiatric illness or multi-system organ failure
Hepatic insufficiency with ASAT, ALAT three times over reference value
Renal insufficiency with creatinin value three times over reference value.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01101529

Locations

Sweden
Uppsala University Hospital	Recruiting
Uppsala, Sweden, 75185
Contact: Gunnar Birgegard +46186110000 ext 14412 gunnar.birgegard@medsci.uu.se
Principal Investigator: Gunnar Birgegard, Prof

Sponsors and Collaborators

Uppsala University Hospital

Investigators

Principal Investigator:

Gunnar Birgegard, MD, PhD

University Hospital, Uppsala, Sweden

More Information

No publications provided

Responsible Party:	Gunnar Birgegård, MD, PhD, professor, Dept of Haematology, University Hospital, Uppsala
ClinicalTrials.gov Identifier:	NCT01101529 History of Changes
Other Study ID Numbers:	EudraCT nr: 2009-010545-31, 2009-010545-31
Study First Received:	April 9, 2010
Last Updated:	July 22, 2010
Health Authority:	Sweden: Medical Products Agency

Keywords provided by Uppsala University Hospital:

Chemotherapy-induced nausea and vomiting CINV

Additional relevant MeSH terms:

Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Antiemetics
Aprepitant
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012